New 510k for change to Intended Use - Prescription to OTC

Bonebuilder

Starting to get Involved
#1
The fundamental tenet of the 510k process is a demonstration of substantial equivalence. To be considered substantially equivalent a device is required, in comparison to a predicate to:
• have the same intended use as the predicate; and
• have the same technological characteristics as the predicate; 

or
• have the same intended use as the predicate; and
• have different technological characteristics and the information submitted to FDA;
o does not raise new questions of safety and effectiveness; and
o demonstrates that the device is at least as safe and effective as the legally marketed device.​

Intended use is therefore the fundamental of substantial equivalence.

So,

When a manufacturer wishes to change the intended use of a device, particularly where that change is a modification from a Prescription Use to an Over-the-Counter (OTC) use, which the guidance declares is considered a major change requiring submission of a new 510k.

If in those circumstances no predicate using the modified OTC intended use exists how does the manufacturer satisfy the fundamental tenet we identified above?

Or is the answer simply, you can’t you need to submit a PMA?

Anyone care offer an opinion? all welcomed.
 
Last edited:
Elsmar Forum Sponsor
M

MIREGMGR

#2
If your device is the first instance of any product anything like what your device does that is proposed for marketability as OTC, then you may have a hard time avoiding the PMA direction.

If however, in addition to your primary predicate for form and function you can point to another device that is sufficiently similar in clinical use, safety and effectiveness and is OTC, and you can make a sufficient strong argument that your device presents no greater risks than that other device, you might be able to use that second device as a secondary predicate.

Then the question is, does FDA feel like having devices of your type move from being Rx to being OTC?

They might not. History indicates that they regard some device categories as appropriately Rx, and that they operate in that regard on the principle of "if it ain't broke, don't fix it".

Given that issue, I'd think you'd want to establish pretty firmly how they feel about your proposal before you do too much work.
 

Bonebuilder

Starting to get Involved
#3
Thanks Miremgr

That's very interesting and pretty much what I was thinking. YOur idea on a secondary predicate is useful I'll have to make a deep trawl to see if anything on the OTC side comes to the surface.

It's somewhat ironic in this case in that the predicate my clients came to me with, whilst cleared as a class II with Rx use is being openly sold all over the internet..!

Maybe they're not big enough fish for FDA to pursue.

Its certainly not a strategy I would suggest a client should adopt.
 
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